MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM25CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005025X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82219391 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm).As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa).The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto).There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa.The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion.A non-cordis.018 guidewire was used for the procedure.There were no damages observed on the.018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter.There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion.A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture.The saber pta was able to be removed easily from the patient and remained in one piece during removal, and the device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm).As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa).The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto).There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa.The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion.A non-cordis.018 guidewire was used for the procedure.There were no damages observed on the.018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter.There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion.A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture.The saber pta was able to be removed easily from the patient and remained in one piece during removal, and the device was not returned as expected.The product was not returned for analysis.A product history record (phr) review of lot 82219391 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿balloon- burst - at/below rbp¿ could not be confirmed.The cause of the event reported by the customer could not be determined during the analysis.Per the instruction for use (ifu), ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ the ifu also instructs, ¿using fluoroscopy and the radiopaque marker bands, position the catheter at the appropriate location.When an acceptable position has been obtained, inflate the balloon to achieve the desired dilatation.¿ based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event therefore, no actions will be taken at this time.

Event Description

As reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm).As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa).The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto).There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa.The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion.A non-cordis.018 guidewire was used for the procedure.There were no damages observed on the.018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter.There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion.A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture.The saber pta was able to be removed easily from the patient and remained in one piece during removal, and the device was not returned as expected.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: this is an updated complaint conclusion due to product return: as reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm).As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa).The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto).There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa.The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion.A non-cordis.018 guidewire was used for the procedure.There were no damages observed on the.018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter.There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion.A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture.The saber pta was able to be removed easily from the patient and remained in one piece during removal.The product was returned for analysis.One non-sterile saber 5mm25cm 150 unit was received coiled for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, the balloon appeared to have been previously inflated since evidence of fluids are inside the component.No anomalies were found on the unit as received.Functional analysis was successfully performed on the received unit.A lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The balloon was instantly inflated.Next, negative pressure was applied, and the unit was immediately deflated as expected.Neither balloon inflation difficulty nor deflation difficulty- partial or slow was met.No anomalies were found.A product history record (phr) review of lot 82219391 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst at/below rbp¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined as the device passed functional analysis.The balloon was inflated/deflated with no burst or leaks noted and without any issues to the balloon.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.According to the warnings in the safety information in the instructions for use ¿the balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d8, d9, g3, g4, g6, h1, h2, h3, and h10 this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm).As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa).The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto).There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa.The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion.A non-cordis.018 guidewire was used for the procedure.There were no damages observed on the.018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter.There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion.A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture.The saber pta was able to be removed easily from the patient and remained in one piece during removal.The device has now been returned.

• Brand Name: SABER 5MM25CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13863450
• MDR Text Key: 291238575
• Report Number: 9616099-2022-05476
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069561
• UDI-Public: (01)20705032069561(17)240331(10)82219391
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 48005025X
• Device Catalogue Number: 48005025X
• Device Lot Number: 82219391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: -5MM X 20CM BD ULTRAVERSE .018 BALLOON.; -DEMAX PRESSURE PUMP INFLATION DEVICE.; -POCO V18 GUIDE WIRE.
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 56 KG